Every Participant Counts from Enrollment to Study Completion

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In research studies like ADAPTABLE, researchers initially focus on enrolling patients in the study.  Every clinical study has a “target” enrollment number, which is the number of participants researchers hope will enroll in the study. For ADAPTABLE that number is 15,000 participants. Reaching this number is important so that researchers can be certain that the study is representative of the population who will benefit most from knowing the preferred dose of aspirin.

Equally important to enrollment in a research study is retention. Retention is the number of patients who remain in the study until it is completed. Well-intentioned participants occasionally drop out early for a variety of reasons and, of course, they have this right. A guiding principle of clinical research is that study participants can discontinue participation at any time for any reason.

Why is Retention Important?

Retention is important for several key reasons. First, researchers have an ethical obligation to follow the health of every study participant until the end of the study, even if the participant has stopped taking the study drug. To meet this obligation, it is essential for researchers to be able to communicate with study participants and collect information on their health and the occurrence of events, such as hospitalizations, heart attacks, or strokes.

Second, a high participant dropout rate means that researchers might not have enough data to evaluate whether or not the treatment works for everyone. The Food and Drug Association (FDA) is the U.S. agency who approves new drugs or treatments. The FDA considers incomplete participant information as missing data, which can compromise the findings of the study.

Finally, there is a fundamental principal that motivates researchers to retain participants in a study. Researchers and patients alike want to learn as much as possible from a study. To accomplish this, researchers want to understand each and every patient’s journey through a study. Each of those individual journeys teaches us something. Every patient’s story and experience needs to come through and be part of the final results of a study.

ADAPTABLE Principal Investigator Daniel Muñoz with Vanderbilt Medical Center says,

Daniel Muñoz, MD, MPA

“The ADAPTABLE study is only possible because each participant has chosen to join, to contribute to science, and to be part of something bigger than themselves. All of us are in this to help patients by getting closer to the truth about whether there might be a best dose of aspirin. We can only get there by understanding and following the experience of each and every participant in the study. The entire ADAPTABLE team is grateful to the thousands of participants whose commitment through the end of the study will ultimately help patients around the world.”

 

Retention in ADAPTABLE

The goal of retention is to make sure as many participants as possible choose to remain in the study until it ends. In ADAPTABLE, full participation means continuing to take your assigned dose of aspirin and completing a survey every 3 – 6 months. To overcome some of the barriers that participants in ADAPTABLE face, participants are able to switch their dose of aspirin if needed for health reasons, modify their participation level, and change how they complete the study surveys.

The infographic below presents ideas on how researchers and study participants can both work to help improve retention in ADAPTABLE.

Remember, if you have questions or concerns about your participation in ADAPTABLE, or any other research study, you can contact the study team to discuss available options that would make participation more comfortable for you.

 ADAPTABLE research team members understand that a person’s circumstances or motivation to participate can change affecting their decision to remain in the study. Team members will always honor a participant’s choice to change participation or leave the study.

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